Links to the current protocol, Patient Information Sheet(s), Informed Consent Form(s) are provided below. If there has been a recent amendment to the trial please ensure you have R&D approval before using these documents.
Other documents (e.g. Amendments, Case Report Form, Serious Adverse Event Form, Guidelines, GP Letter, Release of Medical Information Form etc) can be found by clicking on the other menu items below. If you cannot find what you are looking for please contact the AZTEC Trial Office.
- Protocol version 3.0 11-Jul-17 [.pdf]
- Patient Information Sheet version 4.0 05-Jul-18 [.pdf]
- Informed Consent Form version 3.0 02-Dec-16 [.pdf]
- GP Letter version 1.0 30-Jul-15 [.pdf]
Version Control Lists
The version numbers and dates of all documents used for the trial are captured on a Version Control List. Links to the Version Control Lists used in this trial are below in reverse date order.
- ISF checklist v5.0 17-Aug-2018 [.pdf]
- Pharmacy version control v3.0 26-Apr-2018 [.pdf]
Amendments
The folders below contain the relevant amended documentation and approval letters. Please ensure that you have R&D approval (if applicable) before using the latest versions of these documents.
- Amendment 01 - Addition of new site/change of PI only
- Amendment 02 - Change of site/PI details only
- Amendment 03 [opens new page]
- Amendment 04 [opens new page]
- Amendment 05 [opens new page]
Case Report Forms
- Registration form
- Elligibility form
- Disease History form
- Baseline form
- Treatment cycle form
- GvHD Assessment form
- Adverse Event form
- Concomitant Medication form
- End of Treatment form
- Month 3 and 6 Follow up visit form
- Death form
- Treatment Discontinutation form
- Deviation form
- Withdrawal form
- SAE form
Guidelines
- eCRF User Manual
- SAE completion guidelines
- Sample collection guidelines
Other Trial Documents
- Pharmacy manual
- SAE fax cover sheet
- SmPC - Azacitadine